Morning Briefing
Summaries of health policy coverage from major news organizations
New Cancer Treatments Shows Promise
An experimental immunotherapy developed by Bristol Myers Squibb prevented metastatic melanoma from worsening when added to the company鈥檚 approved treatment, Opdivo, the company said Wednesday. The result is a step forward for immunotherapy, a field that has seen only halting progress since the development of medicines like Opdivo and Merck鈥檚 rival treatment, Keytruda. (Herper, 5/19)
An experimental Bristol Myers Squibb (BMY.N) drug from a new class of immunotherapy used in combination with its big-selling cancer medicine Opdivo significantly extended the time it took for advanced melanoma to worsen compared with Opdivo alone, according to early data from a study released on Wednesday. Patients with previously untreated melanoma that had spread or could not be removed by surgery who received relatlimab plus Opdivo on average went 10.1 months before the deadly skin cancer began to progress, a measure known as median progression-free survival (PFS). That compared with PFS of 4.6 months for those who received Opdivo alone in the study of more than 700 patients. (Erman, 5/19)
When doctors prescribe a personalized cell therapy today, the patient they鈥檙e trying to help has blood cancer so advanced other medicines no longer work. In the future, these so-called CAR-T treatments might be used earlier, for greater benefit, when cancer patients aren鈥檛 so desperately sick. Toward that goal, a CAR-T therapy called cilta-cel from Johnson & Johnson was more effective and better tolerated when used to treat patients with less advanced multiple myeloma, according to preliminary study results released Wednesday. (Feuerstein, 5/19)
There鈥檚 little disputing that an off-the-shelf CAR-T cell therapy for cancer would provide flexibility and convenience over bespoke CAR-T therapies already in use. But can these experimental treatments induce the same kind of durable responses? Allogene on Wednesday said its off-the-shelf CAR-T, called ALLO-501, maintained a 36% complete response rate at six months 鈥 an important measure of response durability 鈥 in patients with large B-cell lymphoma, a common and aggressive type of blood cancer. (Feuerstein, 5/19)
A drug from the Dutch biotech Merus designed to disrupt a rare genetic alteration is showing early but promising anti-tumor responses in patients with advanced pancreatic cancer 鈥 a disease with few effective treatment options available. When treated with infusions of the Merus drug, called zenocutuzumab, four of 10 patients with pancreatic cancer showed partial responses, for a confirmed overall response rate of 40%. Another three patients had minor tumor responses. (Feuerstein, 5/19)
Hours after the biotech company Iovance announced yet another regulatory delay for its investigational cancer treatment, the firm disclosed Wednesday that its CEO had abruptly tendered her resignation, sending its share price plummeting. Maria Fardis, who has run Iovance since 2016, informed the company on Tuesday that she 鈥渨ill be resigning鈥 from her roles as CEO, president, and board member, the firm said in a two-sentence filing with the Securities and Exchange Commission. Iovance did not specify whether Fardis鈥檚 resignation was effective immediately, and the company did not immediately respond to an inquiry. (Garde, 5/19)
And more health industry news 鈥
A promotional campaign has sparked a legal dispute between Spark Therapeutics and Bluebird Bio (BLUE) over the use of a single word: spark. As Bluebird works toward winning U.S. regulatory approval for a gene therapy to combat sickle cell disease, the company created a website and videos designed to provide greater awareness of the illness. And its effort uses such slogans as 鈥淟et鈥檚 Spark Change in Sickle Cell鈥 and 鈥淏e the Spark.鈥 The company is also seeking four trademarks for 鈥淚 AM THE SPARK鈥 and 鈥淪PARK CHANGE,鈥 among other phrases. (Silverman, 5/19)
On Wednesday, five health data analytics companies announced they have banded together to form an industry consortium that aims to transform the way new drugs and devices make their way to patients. The digitization of medical records has opened up access to reams of data about patient outcomes in the past decade, but not all of it has found a use. 鈥淩eal-world data, in and of itself, is not that interesting, right?鈥 said Michael Vasconcelles, chief medical officer of Flatiron Health, the initiator of the new alliance. 鈥淚t鈥檚 really the insights that one gleans from asking important scientific questions that then can be answered or informed by those data.鈥 (Palmer, 5/19)
Ro, the parent company of Roman, the brand that is best known for delivering erectile dysfunction and hair loss medication to consumers, announced on Wednesday that it would acquire Modern Fertility, a start-up that offers at-home fertility tests for women. The deal is priced at more than $225 million, according to people with knowledge of the acquisition who spoke on condition of anonymity because the information was not public. It is one of the largest investments in the women鈥檚 health care technology space, known as femtech, which attracted $592 million in venture capital in 2019, according to an analysis by PitchBook. (Haridasani Gupta, 5/19)